"Transcranial Doppler Assessment of Cerebral Embolization During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement: Comparison of High-dose Aspirin Versus Warfarin Plus Low-dose Aspirin"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Differences in the rate of doppler-detected cerebral micro emboli between the two prophylactic treatments of thrombosis
研究概览
简要总结
The purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used at University of Ottawa Heart Institute for the first three months after surgery in low-risk patients undergoing aortic valve replacement with a bioprosthetic valve: 1) daily use of high-dose aspirin [325 mgs], and 2) the combination of oral Warfarin [target INR 2.0 to 3.0] and low-dose aspirin [81 mg].
详细描述
Background:
There are several medications used to prevent blood clotting in patients undergoing surgical replacement of their aortic valves with tissue valves. One of these medications is called warfarin (Coumadin ®) which prevents blood clotting by making the blood "thinner." Another medication is aspirin which prevents the aggregation (clustering) of cells in the blood called platelets. Some clinicians consider that using only aspirin should be enough to protect the patients against the presence of clots in the blood, but others consider that aspirin should be combined with warfarin for better protection. Moreover, physicians express concern over the use of oral anticoagulation due to the possibility of an increased risk of bleeding. The effects of these medications for preventing blood clots traveling to the brain after the surgery are currently unknown. Transcranial doppler ultrasound will be used in these patients to evaluate non-invasively the quantity of fragments of clots circulating in the arteries of the brain. In addition, platelet function will be measured to determine how effective these treatments are for preventing the aggregation of the blood cells called platelets, which may be involved in clot formation.
Objective:
Our purpose is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used in our institution for the first three months after surgery in these patients: 1) daily use of high-dose aspirin [325 mgs], and 2) the combination of oral Warfarin [target INR 2.0 to 3.0] and low-dose aspirin [81 mg].
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary aortic valve replacement with bioprosthetic (tissue) valve.
排除标准
- •Emergency surgery or redo operations.
- •Patients with history of transient ischemic attacks, stroke, or history of carotid stenosis greater than 50% as detected by carotid duplex doppler or angiography.
- •Patients with COPD who are CO2 retainers.
- •Patients with LV function less than 50%, or enlarged left ventricle greater than 50 mm as detected by echocardiography or previous history of thromboembolism.
- •Patients with history of atrial fibrillation or heart rhythm disturbances.
结局指标
主要结局
Differences in the rate of doppler-detected cerebral micro emboli between the two prophylactic treatments of thrombosis
时间窗: 1 month after surgery
次要结局
- Differences in the degree of inhibition of platelet aggregation between the two prophylactic treatments of thrombosis(1 month after surgery)
研究者
Marc Ruel MD MPH FRCSC
Dr.
Ottawa Heart Institute Research Corporation
